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" In lieu of §211.100 such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification Is conducted on such containers/closures by the manufacturer and provided that the manufacturer... "
GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their ... - 39. lappuse
autors: Leonard Steinborn - 2004 - 452 lapas
Ierobežota priekšskatīšana - Par šo grāmatu

Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 200 lapas
...name of the material sampled, the lot number, the container from which the sample was taken, the data on which the sample was taken, and the name of the...supplier's test results at appropriate intervals. 21 CFR Ch. I (4-1-97 Edition) (3) Containers and closures shall be tested for conformante with all...
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The Code of Federal Regulations of the United States of America

1994 - 196 lapas
...taken, the data on which the sample was taken, and the name of the person who collected the sample. (в) Containers from which samples have been taken shall...with all appropriate written procedures. In lieu of §211.100 such testing by the manufacturer, a certificate of testing may be accepted from the supplier,...
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The Code of Federal Regulations of the United States of America

1993 - 192 lapas
...exist, shall be used. (2) Each component shall be tested for conformity with all appropriate Bitten specifications for purity, strength, and quality....intervals. (3) Containers and closures shall be tested for conf ormance with all appropriate written procedures. In lieu of such testing by the manufacturer,...
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The Code of Federal Regulations of the United States of America

1989 - 240 lapas
...the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals....
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The Code of Federal Regulations of the United States of America

2003 - 210 lapas
...the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals....
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The Code of Federal Regulations of the United States of America

1992 - 192 lapas
...the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals....
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 200 lapas
...supplier, provided that at least a visual identification is con-ducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reli-ability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals....
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The Code of Federal Regulations of the United States of America

1979 - 190 lapas
...test shall be conducted to verify the identity of each component of a drug product. Specific identify tests, if they exist, shall be used. (2) Each component...intervals. (3) Containers and closures shall be tested for conf ormance with all appropriate written procedures. In lieu of such testing by the manufacturer,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1979 - 266 lapas
...for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of ana1ysis may be accepted from the supplier of a component,...intervals. (3) Containers and closures shall be tested for conf ormance with all appropriate written procedures. In lieu of such testing by the manufacturer,...
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Infant Formula Act of 1980: Hearing Before the Subcommittee on Health and ...

United States. Congress. Senate. Committee on Labor and Human Resources. Subcommittee on Health and Scientific Research - 1980 - 180 lapas
...accepted from the supplier of a component, provided that one specific identity test is conducted on each component by the manufacturer, and provided that the...manufacturer establishes the reliability of the supplier's analysis at appropriate intervals. 2. With respect to the controls exercised over each batch of infant...
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